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This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edaravone | Experimental |
| |
| Ozagrel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edaravone | Drug | Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Rate of Patients With a Modified Rankin Scale Score of 0-1 | The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Barthel Index Score | The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state. The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yukito Shinohara, MD | Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19321945 | Result | Shinohara Y, Saito I, Kobayashi S, Uchiyama S. Edaravone (radical scavenger) versus sodium ozagrel (antiplatelet agent) in acute noncardioembolic ischemic stroke (EDO trial). Cerebrovasc Dis. 2009;27(5):485-92. doi: 10.1159/000210190. Epub 2009 Mar 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Edaravone | Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. |
| FG001 | Ozagrel | Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Edaravone | Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. |
| BG001 | Ozagrel | Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Barthel Index Score | The Barthel Index of Activities of Daily Living measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state. The number of patients with 95-100 Barthel Index was evaluated at at 3 months after treatment initiation. | Posted | Number | participants | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Edaravone | Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomotic ulcer haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| C034364 | ozagrel |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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| Sodium Ozagrel | Drug | Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening. |
|
| 3 months |
| Baseline NIH Stroke Scale Score | The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). | Before treatment initiation |
| NIH Stroke Scale Score at 14 Days | The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation. | 14 days |
| NIH Stroke Scale Score at 1 Month | The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation. | 1 month |
| NIH Stroke Scale Score at 3 Months | The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation. | 3 months |
| Japan Stroke Scale (Motor Function) Score at 14 Days | The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation. | 14 days |
| Japan Stroke Scale (Motor Function) Score at 1 Month | The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation. | 1 month |
| Japan Stroke Scale (Motor Function) Score at 3 Months | The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation. | 3 months |
| Modified Rankin Scale Score | The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability. | 6 months |
| Nontreatment |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Ozagrel |
Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening. |
|
|
| Secondary | Baseline NIH Stroke Scale Score | The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). | Posted | Mean | Standard Deviation | scores on a scale | Before treatment initiation |
|
|
|
| Secondary | NIH Stroke Scale Score at 14 Days | The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 14 days after treatment initiation. | Posted | Number | participants | 14 days |
|
|
|
| Secondary | NIH Stroke Scale Score at 1 Month | The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 1 month after treatment initiation. | Posted | Number | participants | 1 month |
|
|
|
| Primary | the Rate of Patients With a Modified Rankin Scale Score of 0-1 | The number of patients with mRS score of 0-1 (good outcome) at 3 months after treatment initiation. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability. | Posted | Number | participants | 3 months |
|
|
|
| Secondary | NIH Stroke Scale Score at 3 Months | The NIH stroke scale is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from 0 (no deficit) to 42(dead). The number of patients with NIH stroke scale score of 0-1 at 3 months after treatment initiation. | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Japan Stroke Scale (Motor Function) Score at 14 Days | The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 14 days after treatment initiation. | Posted | Mean | Standard Deviation | units on a scale | 14 days |
|
|
|
| Secondary | Japan Stroke Scale (Motor Function) Score at 1 Month | The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 1 month after treatment initiation. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
|
|
| Secondary | Japan Stroke Scale (Motor Function) Score at 3 Months | The Japan stroke scale (motor function) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Values range from -0.26 (no deficit) to 31.29 (worst). The mean of Japan stroke scale (motor function) score at 3 months after treatment initiation. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Modified Rankin Scale Score | The number of patients with an Modified Rankin Scale score of 0-1 was evaluated at 6 months after treatment initiation. The Modified Rankin Scale has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability. | Posted | Number | participants | 6 months |
|
|
|
| 27 |
| 194 |
| 102 |
| 194 |
| EG001 | Ozagrel | Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening. | 28 | 198 | 107 | 198 |
| Angina pectoris | Cardiac disorders | MedDRA 9.1 |
|
| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 9.1 |
|
| Arrhythmia | Cardiac disorders | MedDRA 9.1 |
|
| Arteriosclerosis | Vascular disorders | MedDRA 9.1 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 9.1 |
|
| Cardiac failure | Cardiac disorders | MedDRA 9.1 |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 9.1 |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 9.1 |
|
| Cerebral infarction | Nervous system disorders | MedDRA 9.1 |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 |
|
| Depression | Psychiatric disorders | MedDRA 9.1 |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 9.1 |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 9.1 |
|
| Erysipelas | Infections and infestations | MedDRA 9.1 |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 9.1 |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 9.1 |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 9.1 |
|
| Hemiplegia | Nervous system disorders | MedDRA 9.1 |
|
| Ileus | Gastrointestinal disorders | MedDRA 9.1 |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 9.1 |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 9.1 |
|
| Loss of consciousness | Nervous system disorders | MedDRA 9.1 |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 9.1 |
|
| Pharyngitis | Infections and infestations | MedDRA 9.1 |
|
| Pneumonia | Infections and infestations | MedDRA 9.1 |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 |
|
| Psychotic disorder due to a general medical condition | Psychiatric disorders | MedDRA 9.1 |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 9.1 |
|
| Sciatica | Nervous system disorders | MedDRA 9.1 |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 9.1 |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 9.1 |
|
| Thrombotic stroke | Nervous system disorders | MedDRA 9.1 |
|
| Transient ischemic attack | Nervous system disorders | MedDRA 9.1 |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 9.1 |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.1 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 9.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 9.1 |
|
| Headache | Nervous system disorders | MedDRA 9.1 |
|
| Insomnia | Psychiatric disorders | MedDRA 9.1 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.1 |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 |
|
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| Death |
|